FDA DeviceClass IINotable

FDA Recall: BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are

Date: 2026-06-24
Brand: BD SWITZERLAND SARL
Category: Medical Device
FDA Class: Class II

Description

Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

Hazard

Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

Remedy

2,465,500 units

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